Article excerpt

As far as anyone can tell, the biggest threat from the world's
first transgenic pet might be that it keeps a few goldfish awake at
night.

But for opponents of transforming animals through bioengineering,
the red glow emanating from the new GloFish might as well be a five-
alarm fire.

Because the US government quickly agreed the fish was safe,
concern is spreading that regulatory oversight of transgenic animals
may be flawed.

A long line of genetically modified animals are under study: flea-
resistant dogs, cats with nonallergenic fur, and designer mosquitoes
that could outbreed the current pests but would be incapable of
carrying diseases such as malaria. Thus, the tiny and innocuous
GloFish has plunged the scientific and regulatory communities into
murky waters.

"All the experts I've talked to don't have concerns about this
particular fish, but it is the precedent for what else is coming;
and what are the rules by which those fish or animals are going to
be judged?" asks Michael Rodemeyer, director of the Pew Initiative
on Food and Biotechnology in Washington. "The question is, we think
they're safe, but how do we really know unless somebody has looked
at some data and made a decision about that?"

Some officials aren't ready to offer their blessing. On Dec. 4,
the California Fish and Game Commission banned the sale of GloFish.
Other states are studying whether to ban or regulate these and other
transgenic fish. While glowing mice, insects, and rabbits have been
bred in laboratories, GloFish represent the first transgenic animals
that Americans can take home as pets.

But in a brief statement Dec. 9, the Food and Drug Administration
(FDA) said it would not regulate GloFish because they posed no
threat to the food supply or "any more threat to the environment
than their unmodified counterparts which have long been widely sold
in the United States."

Ban on GloFish

Consumer and environmental watchdog groups have reacted with
alarm. Last week, the Center for Technology Assessment and the
Center for Food Safety filed suit seeking a court order to stop the
sale of GloFish pending federal approval.

A report issued Tuesday by the National Research Council also
raises concerns about the release of bioengineered animals into the
wild. It calls for new research to identify more clearly the
ecological risks of genetically modified organisms, including
plants, animals, and microbes. It also cites the need for better
confinement through isolation and other means, such as
sterilization.

"The evaluation of whether and how to confine cannot be an
afterthought in the development of a transgenic organism," the
report warns. "Safety must be a primary goal from the start of any
project."

Genetic scientists agree that it's unlikely GloFish themselves
pose a threat, since they wouldn't flourish in the wild.

The fish were created by scientists at the University of
Singapore who injected a sea coral gene for red fluorescence into
zebrafish embryos. The fish were intended to act as environmental
markers, glowing only when they encountered ocean pollutants. But
the fish's glow turned out to be always "turned on," quashing that
idea.

The GloFish for sale in American pet stores, distributed by
Yorktown Technologies of Austin, Texas, are descendants of these
genetically altered fish, which continue to express red
fluorescence. (They shine most intensely under black light.)

As regulations now stand, the FDA bears most of the
responsibility for regulating transgenic animals. In the past, the
agency has said that all genetically altered creatures constitute
"new drugs" and thus would fall under its review. The FDA's
inattention to the GloFish seems to suggest a change in policy.

"The responsibilities of federal agencies for regulating animal
biotechnology are unclear," concludes a 2002 report from the
National Academies of Science, which also noted "a concern about the
legal and technical capacity of the [federal] agencies to address
potential hazards, particularly in the environmental area. …

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